A Review of the FDA’s Electronic Drug Registration and Listing System

In 2010, the US Federal Drug Administration (FDA) revolutionized how drug manufacturers registered their facilities and listed their products.

That year saw the introduction of an electronic Drug Registration and Listing System (DRLS). Since that time, the FDA has continued to refine and focus their DRLS process. As one of the leading third party FDA registration services, B&R Compliance has a front row seat to all the changes. Over the last two years, the FDA has begun to review its databases and has been either removing some registration information or contacting firms and telling them to update their information on file with the FDA. This article will review how this system has evolved, what is now required to be filed with FDA, how to check your information in FDA’s databases, and some of the common problems the FDA is addressing.

Structured Product Labeling